Notice to Stakeholders - New name for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP)

February 11, 2013

Good Pharmacovigilance Practices (GVP) is the new name for the Post-Market Reporting Compliance (PMRC) inspection program. This program supports the Inspectorate mandate by verifying that manufacturers of pharmaceutical, radiopharmaceutical and biological drugs marketed in Canada for human use are in compliance with the regulatory requirements for the receipt, analysis and submission of drug safety information to Health Canada.

This change is being made in order to harmonize our terminology with our international regulatory partners and will not affect how Health Canada continues to work with manufacturers marketing drugs in Canada. Manufacturers are still required to comply with Divisions 1 and 8 of the Food and Drug Regulations, including the adverse drug reaction reporting and reporting of failure in efficacy of new drug. The Inspectorate program provides pertinent information and promotes voluntary compliance with Canadian regulatory requirements, where compliance is assessed by conducting inspections with a different cycle frequencies of these establishments based on a priority ranking scale and a risk-based approach.

It is the responsibility of the Inspectorate Program and the Marketed Health Products Directorate (MHPD) to collaborate and act in partnership in the application of this Inspection Strategy. It is the Inspectorate program's responsibility to perform inspections and provide the data to MHPD and it is the responsibility of MHPD to analyze the data.

Any inquiries about this change may be submitted to the Manager, Drug GMP Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. 2006D, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613-957-6709, or by email at GVP-BPV@hc-sc.gc.ca

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